Myelodysplastic Syndromes (MDS)NCT02779569
A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)
A study testing decitabine in people with Myelodysplastic Syndromes (MDS), run by The First Affiliated Hospital with Nanjing Medical University at 6 sites in China.
Trial summary
To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelodysplastic Syndromes (MDS)
- What is being tested?
- decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesChina
- Study dates
- Mar 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 to 80 years;
- Patients at high risk of MDS assessed by International Prostate Symptom Score (IPSS);
- Chronic myelomonocytic leukemia (CMML) patients with abnormal white blood cell counts, extremely low platelet count or organ infiltration (such as hepatomegaly, splenomegaly) that required therapy;
- Patients at low risk of MDS identified by IPSS score who had secondary MDS, platelet count of < 20*10^9/L, no response to erythropoietin (EPO) (non-5q deletion syndrome) in the presence of disease symptoms or blood transfusion dependence, or no response to EPO/lenalidomide (5q deletion syndrome) in the presence of disease symptoms or blood transfusion dependence;
- Patients with a Eastern Cooperative Oncology Group (ECOG) of 0 to 2;
- Patients with an expected lifespan of over 6 months;
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- Patients with a aspartate aminotransferase (AST) of < 2.5 times higher than the normal upper limit, alanine aminotransferase (ALT) of < 2.5 times higher than the normal upper limit, total bilirubin of < 1.5 times higher than the normal upper limit, and serum creatinine of < 1.5 times higher than the normal upper limit;
- Subjects who had recovery of toxicity, did not undergo any therapy 4 weeks prior to the first trial, and did not receive nitrosourea therapy and bone marrow transplantation 6 weeks prior to the first trial;
- Female subjects were menopausal, underwent surgical sterilization, or had effective contraception (oral contraceptive, injectable contraceptive, intrauterine device, contraceptive patch, male sterilization) prior to enrollment and during the trial, and were negative for serum or urine pregnancy test at screening;
- No insemination was given to male subjects during the treatment and within 2 months post-treatment;
- Subjects complying with the study protocol;
- Subjects that signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.
Who cannot join
- Patients that were diagnosed as acute myeloid leukemia (primitive bone marrow cell proportion of 20% or higher) or other progressive malignant diseases;
- Patients that received treatment with other drugs within 30 days prior to the first administration of decitabine;
- Patients that received radiotherapy within 14 days prior to the first administration of decitabine;
- Patients with uncontrolled heart disease or congestive heart failure;
- Patients with uncontrolled restrictive or obstructive pulmonary disease;
- Patients with active viral, bacterial or invasive fungal infections;
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- Patients that were complicated by autoimmune hemolytic anemia or immune thrombocytopenia;
- Patients with a history of use of azacitidine or decitabine;
- Patients that were sero-positive for HIV;
- Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up;
- Patients bone marrow cannot be sampled;
- Subjects that were allergic to decitabine vehicle;
- Pregnant or lactating women.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, 310000
Jianping Shen, ouyangguifang@medmail.com.cn
Jianping Shen
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangsheng He
Guangsheng He
- Not yet recruiting
No.303 Hospital of Chinese People's Liberation Army
Nanning, Guangxi, 530021
Xiaolin Yin, 13321717899@163.com
Xiaolin Yin
- Recruiting
Shengjing Hospital of China Medical Univercity
Shenyang, Liaoning, 110022
Wei Yang, yangw@sj-hospital.org
Wei Yang
- Not yet recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
Xiaomin Wang, wxm201304@163.com
Xiaomin Wang
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Mei Zhang, zhangmei@medmail.com.cn
Mei Zhang
About this study
Official title: Prospective, Open, Multi-center, Double Arm Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)
To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS
Read the detailed description
To develop a highly effective and safe protocol, a multi-center, prospective clinical trial was conducted in China, with aims to evaluate the grade III and IV hematologic toxicity and clinical efficacy of subcutaneous injection of ultra-low-dose decitabine (5 to 7 mg/m2) for treatment of myelodysplastic syndrome (MDS), while decitabine at a dose of 20 mg/m2 as a control.
- Conditions
- Myelodysplastic Syndromes (MDS)
- Being tested
- decitabine
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ultra-low-dose group | Experimental | decitabine was subcutaneously administered at 5 to 7 mg/m2 once daily for successive 3 days at the first week, and once daily at weeks 2 to 4, with a total dose of 60 mg in a 4-week cycle. Receives: Drug: decitabine |
| Low-dose group | Active comparator | decitabine was subcutaneously given at 20 mg/m2 once daily for successive 3 days, with a total dose of 60 mg/m2 in a 4-week cycle. Receives: Drug: decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade III and IV hematologic toxicity, according to National Cancer Institute common toxicity criteria (NCI-CTC) V3.0 criteria
Measured: 8 months
Secondary outcomes (9)
Complete response, according to International Working Group (IWG) response criteria
Measured: 8 months
Complete response (CR) rate of bone marrow, according to IWG response criteria
Measured: 8 months
Partial response (PR) rate, according to IWG response criteria
Measured: 8 months
Hematologic improvement (HI), according to IWG response criteria
Measured: 8 months
Overall response rate, defined as CR＋PR＋HI, according to IWG response criteria
Measured: 8 months
Cytogenetic response, according to IWG response criteria
Measured: 8 months
times of transfusion requirements
times of transfusion requirements during 8 months after enrollment
Measured: 8 months
times of hospitalization
times of hospitalization during 8 months after enrollment
Measured: 8 months
The quality of life, the quality of life will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndromes (MDS)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangsheng He, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779569
- Sponsor's protocol ID
- MDS-ULD-2016
- Other IDs
- ChiCTR-IPR-16008100
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Multi-center, Double Arm Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)
- ClinicalTrials.gov ID
- NCT02779569
- Acronym / sponsor ID
- MDS-ULD-2016
- Conditions
- Myelodysplastic Syndromes (MDS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and clinical efficacy of ultra-low-dose decitabine in Chinese MDS
Detailed description
To develop a highly effective and safe protocol, a multi-center, prospective clinical trial was conducted in China, with aims to evaluate the grade III and IV hematologic toxicity and clinical efficacy of subcutaneous injection of ultra-low-dose decitabine (5 to 7 mg/m2) for treatment of myelodysplastic syndrome (MDS), while decitabine at a dose of 20 mg/m2 as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-low-dose group | Experimental | Drug: decitabinedecitabine was subcutaneously administered at 5 to 7 mg/m2 once daily for successive 3 days at the first week, and once daily at weeks 2 to 4, with a total dose of 60 mg in a 4-week cycle. |
| Low-dose group | Active comparator | Drug: decitabinedecitabine was subcutaneously given at 20 mg/m2 once daily for successive 3 days, with a total dose of 60 mg/m2 in a 4-week cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or women aged 18 to 80 years;
- Patients at high risk of MDS assessed by International Prostate Symptom Score (IPSS);
- Chronic myelomonocytic leukemia (CMML) patients with abnormal white blood cell counts, extremely low platelet count or organ infiltration (such as hepatomegaly, splenomegaly) that required therapy;
- Patients at low risk of MDS identified by IPSS score who had secondary MDS, platelet count of < 20*10^9/L, no response to erythropoietin (EPO) (non-5q deletion syndrome) in the presence of disease symptoms or blood transfusion dependence, or no response to EPO/lenalidomide (5q deletion syndrome) in the presence of disease symptoms or blood transfusion dependence;
- Patients with a Eastern Cooperative Oncology Group (ECOG) of 0 to 2;
Key exclusion criteria (13 listed)
- Patients that were diagnosed as acute myeloid leukemia (primitive bone marrow cell proportion of 20% or higher) or other progressive malignant diseases;
- Patients that received treatment with other drugs within 30 days prior to the first administration of decitabine;
- Patients that received radiotherapy within 14 days prior to the first administration of decitabine;
- Patients with uncontrolled heart disease or congestive heart failure;
- Patients with uncontrolled restrictive or obstructive pulmonary disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decitabine | Drug | Low-dose group, Ultra-low-dose group |
Primary outcome
Grade III and IV hematologic toxicity, according to National Cancer Institute common toxicity criteria (NCI-CTC) V3.0 criteria
Time frame: 8 months
9 secondary outcomes
Complete response, according to International Working Group (IWG) response criteria
Time frame: 8 months
Complete response (CR) rate of bone marrow, according to IWG response criteria
Time frame: 8 months
Partial response (PR) rate, according to IWG response criteria
Time frame: 8 months
Hematologic improvement (HI), according to IWG response criteria
Time frame: 8 months
Overall response rate, defined as CR＋PR＋HI, according to IWG response criteria
Time frame: 8 months
Cytogenetic response, according to IWG response criteria
Time frame: 8 months
times of transfusion requirements
Time frame: 8 months
times of hospitalization
Time frame: 8 months
The quality of life, the quality of life will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30)
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: Undecided
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangsheng He principal investigator
The First Affiliated Hospital with Nanjing Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decitabine in people with Myelodysplastic Syndromes (MDS), run by The First Affiliated Hospital with Nanjing Medical University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangsheng He, MD.PhD (008615312052789, heguangsheng@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade III and IV hematologic toxicity, according to National Cancer Institute common toxicity criteria (NCI-CTC) V3.0 criteria (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.